11 results
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19ms
·
Sources: EU EUDAMED, US FDA
Implant-One System
FDA 510(k)
FDA Class 2
·Dental
Split Cath®
FDA UDI
Medical Components, Inc.·00884908089295·14F X 55CM Split Cath®III CATHETER SET (CUFF 50...
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981159153·Lateral Implant, 23mm x 14mm x 55mm, 15 Deg
Regatta Lateral System
FDA UDI
Seaspine Orthopedics Corporation·10889981159146·Lateral Implant, 23mm x 14mm x 55mm, 10 Deg
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
RESTORE MODULAR STERILIZATION TRAY SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
CONKLUSION PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·November 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022